S1057 A Randomized Phase I Study Comparing Pharmacokinetics, Safety and Immunogenicity of High Concentration Formulation (100 mg/mL) With GP2017 Formulation (50 mg/mL), an Adalimumab Biosimilar, in Healthy Male Subjects

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Published inThe American journal of gastroenterology Vol. 117; no. 10S; pp. e765 - e766
Main Authors Rondon, Juan Carlos, Von Richter, Oliver, Fey, Constanze, Fan, Jamie, Furlan, Fabricio, Lemke, Lena
Format Journal Article
LanguageEnglish
Published Philadelphia, PA Wolters Kluwer 01.10.2022
Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins
Subjects
Online AccessGet full text
ISSN0002-9270
1572-0241
DOI10.14309/01.ajg.0000860868.50770.0c

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Author Fan, Jamie
Furlan, Fabricio
Von Richter, Oliver
Rondon, Juan Carlos
Fey, Constanze
Lemke, Lena
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References Von Richter O, et al. Expert Opin Biol Ther. 2019;19(10):1075-1083.
Von Richter (R1-20230201) 2019; 19
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SubjectTerms Biological products
Gastroenterology
Monoclonal antibodies
Pharmacokinetics
TNF inhibitors
Title S1057 A Randomized Phase I Study Comparing Pharmacokinetics, Safety and Immunogenicity of High Concentration Formulation (100 mg/mL) With GP2017 Formulation (50 mg/mL), an Adalimumab Biosimilar, in Healthy Male Subjects
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